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What action will be taken if you find that the supplier is not control

HARPC supplier controlling hazards supply-chain applied control supplier management preventive controls 21 CFR Part 117

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Posted 07 June 2018 - 04:15 PM

Hi, we are regulated in the United States under 21 CFR Parts 117 and 111 and manufacture dietary supplements.


For those of you under Part 117, for §117.410(e), if you find that the supplier is not controlling a hazard that the receiving facility has identified as requiring a supply-chain-applied control, what would you do?


Would you quarantine product, drop the supplier, do additional testing, or a combination of these?


Thank you,




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Posted 07 June 2018 - 06:38 PM

Do a set-aside with testing,  find an emergency supplier while you offer assistance to the supplier to get them back into control - and if that did not work, dump them.

Kind regards,
Glenn Oster
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Also tagged with one or more of these keywords: HARPC, supplier, controlling hazards, supply-chain applied control, supplier management, preventive controls, 21 CFR Part 117

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